3.
Prescription
opioids are narcotics. They are derived
from and possess properties similar to opium and heroin, and they are regulated
as controlled substances. While opioids can
dampen the perception of pain, they also can create an addictive, euphoric high. At higher doses, opioids can slow the user’s
breathing, causing potentially fatal respiratory depression. Most patients receiving more than a few weeks
of opioid therapy will experience often prolonged withdrawal symptoms—including
severe anxiety, nausea, headaches, tremors, delirium, and pain—if opioid use is
delayed or discontinued. When using
opioids continuously, patients grow tolerant to their analgesic
effects—requiring progressively higher doses and increasing the risks of
withdrawal, addiction, and overdose.

4.
Because
the medical community recognized the dangers of opioid use, they originally used
opioids cautiously and sparingly, typically only for short-term acute pain—where
brief use limited the need for escalating doses and the risk of addiction—or for
palliative (end-of-life) care.[1] Consequently, the market for prescription
opioids was sharply restricted.

5.
As
Purdue developed OxyContin in the mid-1990s, it knew that to expand its market
and profits, it needed to change the perception of opioids to permit and
encourage the use of opioids long-term for widespread chronic conditions, like
back pain, migraines, and arthritis. Purdue,
together with the other Defendants, helped cultivate a narrative that pain was
undertreated and that pain treatment should be a higher priority for health
care providers. This effort paved the
way for increased prescribing of opioids for chronic pain. Defendants’ promotional efforts dovetailed with
this narrative, as Defendants began to promote opioids generally, and their own
opioids in particular, as safe, effective, and appropriate for even long-term
use for routine pain conditions. As part
of this strategy, Defendants misrepresented to prescribers and consumers the
risk of addiction for pain patients as modest, manageable, and outweighed by the
benefits of opioid use.

6.
Between
the 1990s and 2011, prescriptions of oxycodone, an active ingredient in opioid
drugs manufactured by Defendants and others, more than doubled in the United
States. During the same time period,
opioid prescriptions increased some 31% from approximately 1.6 million to
approximately 2.2 million. According to
a U.S. Department of Health and Human Services Fact Sheet, “[i]n 2014, more
than 240 million prescriptions were written for prescription opioids, which is
more than enough to give every American adult their own bottle of pills.”

7.
Defendants’
deceptive marketing efforts continued over the next several years, eventually triggering
investigations by numerous state and federal entities. In 2007, Purdue and three of its executives
pled guilty to federal criminal charges for deceptively marketing opioids and
reached civil settlements with 26 States (not including New Jersey) and the
District of Columbia. However, rather
than reforming its opioid marketing to comply with the law, Purdue continued to
mislead and obfuscate, as did the other Defendants.

8.
To
this day, Defendants have failed to correct their earlier misrepresentations, and,
in many respects, persist in the same types of misconduct.

9.
Defendants
spent hundreds of millions of dollars on promotional activities and materials
that continued to falsely deny or trivialize the risk of addiction and
overstated the benefits of opioids. Defendants
deceptively marketed opioids to prescribers and consumers through advertising,
websites, and in-person sales calls. Defendants
also relied upon continuing medical education (“CME”) seminars, non-credit
education programs, treatment guidelines, and other publications and programs
by patient advocacy groups, professional associations, and physicians that were
flawed and misleading, but seemed independent and therefore credible.

10.
Through
these efforts, Defendants were able to persuade doctors and consumers that
opioids were not addictive, despite the previous medical consensus and
scientific evidence to the contrary. Defendants
convinced prescribers and consumers that, even if opioids had some limited
potential to be addictive, any risk of addiction could be managed by doctors
carefully supervising their use by appropriate patients. Part of Defendants’ message was that doctors should
treat the right patients: legitimate patients who took the drugs as directed
(orally) to treat their pain, rather than abusers seeking to snort or inject
the drugs for recreation. By defining
the class of individuals who should not receive opioids as only these abusers, Defendants
gave doctors and consumers a false sense of security that they could safely
prescribe opioids to patients they trusted.

11.
In
persuading doctors that nearly all patients could safely receive opioids, Defendants
expressly appealed to the doctors’ desire to alleviate their patients’
suffering. Doctors were receptive to Defendants’
message because, after hearing about the scourge of untreated and undertreated
pain, they needed a way to safely and effectively relieve that pain. Once doctors grabbed onto Defendants’ narrative,
the consequence that doctors stopped worrying about signs of addiction or prescribing
too high doses followed.

12.
In
2007, Purdue and three of its executives pled guilty to federal charges for misleading
doctors, patients, and regulators about the risk of addiction and OxyContin’s
potential to be abused. As described in
its plea agreement, Purdue systematically misrepresented the risk of addiction,
including promising that opioid addiction occurred in less than 1% of patients and
that opioids were not addictive when legitimately prescribed. This was how Purdue explained away what
doctors had previously believed about opioids:
it was not that opioids were not addictive, but rather opioids would not
addict patients under a doctor’s care.

13.
Purdue’s
guilty plea seemed to have little effect on Purdue’s operations and marketing,
or that of other Defendants. In the
decade that followed, Defendants created and sustained a multi-billion dollar
pain franchise through the same pattern of deceptive marketing. Specifically:

a.
Defendants continued to tell doctors and consumers that
patients receiving opioid prescriptions for pain generally would not become
addicted, and that doctors could use screening tools to exclude patients who
might.

b.
Defendants continued to tell doctors and consumers that
patients who did appear addicted were not; they were instead “pseudoaddicted”
and needed more opioids.

c.
Defendants continued to tell doctors and consumers that
opioids relieved pain when used long-term, without any studies to support this
claim and without disclosing the lack of evidence that opioids were safe or
effective long-term or the other risks from long-term use of opioids.

d.
Defendants continued to tell doctors and consumers that
opioids could be taken in higher and higher doses without disclosing the ensuing
risk to the patient.

e.
Defendant Purdue Pharma continued to tell doctors and
consumers that OxyContin provided 12 hours of relief when Purdue knew that, for
many patients, it did not.

14.
Defendants
also developed new deceptive marketing practices in response to increasing
awareness of the problems with opioids.
Rather than admit responsibility, Defendants simply blamed abuse and
addiction on people snorting or injecting opioids.

15.
In
2010, Purdue obtained approval for an “abuse-deterrent” formulation (“ADF”) of
OxyContin but deceptively marketed it to doctors and consumers, claiming:

a.
Purdue’s ADF opioids could not be crushed or snorted,
which is false.

b.
Purdue’s ADF opioids reduced opioid abuse and
diversion, which is false. Purdue failed to tell doctors and consumers that
its ADF opioids had no impact on oral abuse.

c.
Purdue’s ADF opioids were safer than other opioids,
which is false.

16.
Along
with the launch of reformulated OxyContin, Purdue also launched a new campaign—capitalizing
upon growing concern about the rising tide of opioid addiction, overdose, and
death—falsely promoting the effectiveness of its abuse-deterrent opioids in
preventing abuse. Like pseudoaddiction,
this marketing was intended to, and did, reassure prescribers and consumers who
became concerned about addiction that they not only could continue to prescribe
and take opioids, but in fact needed to switch to Purdue’s opioids because they
were safer.

17.
Purdue
knew, and evidence showed, that Purdue’s reformulated OxyContin, and its
later-released Hysingla, which it also promoted as abuse-deterrent could be
easily defeated, did not affect oral use, which is the most common means of
abuse, and increased harmful outcomes. In
2012, Purdue filed a Citizen Petition[2]
seeking a ruling from the FDA that Purdue’s removal of the original OxyContin
was for safety reasons and generic products approved as bioequivalent to the
older formulation should be removed from the market unless they could
demonstrate similar tamper resistance. This
effort was successful and allowed Purdue to defeat generic competition for the
drug just one day before Purdue faced loss of patent protection. Yet, there were no long-term studies to
support Purdue’s claims, and tellingly, after it successfully removed generic
competition, Purdue in 2015 abruptly withdrew a supplemental new drug
application related to reformulated OxyContin one day before FDA staff were to
release its assessment of the application.
A FDA review acknowledged that “unusual means” could result in
extraction of the active ingredient for snorting or injection.

18.
Similarly,
Endo has marketed Opana ER as tamper- or crush-resistant and less prone to
misuse and abuse since at least May 21, 2011 even though: (1) the FDA rejected
Endo’s petition to approve Opana ER as abuse-deterrent in 2012; (2) the FDA
warned in a 2013 letter that there was no evidence that Opana ER “would
provide a reduction in oral, intranasal or intravenous abuse”; and (3) Endo’s
own studies, which it failed to disclose, showed that Opana ER could still be
ground and chewed. Endo’s advertisements for the 2012 reformulation of Opana ER
falsely claimed that it was designed to be crush resistant, in a way that
suggested it was more difficult to abuse. And since 2012, detailers for Endo
have informed doctors that Opana ER is harder to abuse.

19.
In
its 2016 settlement with Endo, the New York Attorney General found statements
that Opana ER was “designed to be, or is crush resistant” false and misleading
because there was no difference in the ability to extract the narcotic from
Opana ER. The New York Attorney General
also found that Endo failed to disclose its own knowledge of the crushability
of redesigned Opana ER in its marketing to formulary committees and pharmacy
benefit managers.

20.
Because
Opana ER could be “readily prepared for injection” and was linked to outbreaks
of HIV and a serious blood disease, in June 2017, the FDA requested that Endo
withdraw Opana ER from the market. Endo
has since agreed to stop selling Opana.

21.
In
the same vein, Purdue and Endo also misrepresented their efforts to rein in the
diversion and abuse of opioids, while privately failing to report suspicious
prescribing.

22.
Defendants’
scheme was resoundingly successful. Chronic
opioid therapy—the prescribing of opioids long-term to treat chronic pain—has
been a commonplace, and often first-line, treatment since at least the
mid-2000s. While previously a small
minority of opioid sales, today between 80% and 90% of opioids (measured by
weight) used are for chronic pain. In
2015, Purdue reaped an estimated $2.4 billion in revenue, virtually all of it
from opioids. Since its launch in 1996,
OxyContin alone has generated $35 billion in sales.

23.
Defendants’
deceptive marketing caused prescribing not only of Purdue opioids, but of opioids
as a class, to skyrocket. Opioids are
now among the most prescribed classes of drugs.
In 2015, health care providers wrote enough opioid prescriptions to
medicate every American around the clock for three weeks, and on an average
day, more than 650,000 opioid prescriptions are dispensed in the U.S. In 2015, Newark saw more than 1,500 people
admitted for opioid (including heroin)-related substance abuse treatment and
more than 1,600 people sought treatment for these conditions in 2016.

24.
Defendants
knew that their representations regarding the risks and benefits of opioids
were not supported by and/or were directly contrary to the scientific evidence.
Indeed, the U.S. Food and Drug
Administration (“FDA”) confirmed thefalsity of Defendants’ representations in
recent public statements (see ¶ 63 infra.) and the
Centers for Disease Control and Prevention (“CDC”) exhaustively reviewed the
evidence on opioids in its 2016 Guideline
for Prescribing Opioids for Chronic Pain (“CDC Guideline”).

25.
Rather
than compassionately helping patients, this explosion in opioid use—and Defendants’
profits—has come at the expense of chronic pain patients. The CDC concluded in 2016 that “for the vast
majority of [chronic pain] patients, the known, serious, and too-often-fatal
risks [of opioids] far outweigh the unproven and transient benefits.”[3]

26.
As a
direct result of Defendants’ dangerously false marketing, the nation is now embroiled
in what the CDC called a “public health epidemic” and what the U.S. Surgeon
General deemed an “urgent health crisis.”[4]
The increased volume of opioid prescribing correlates directly to skyrocketing
addiction, overdose, and death; black markets for diverted prescription opioids;
and a concomitant rise in heroin and fentanyl abuse by individuals who could no
longer legally acquire—or simply could not afford—prescription opioids.

27.
Every
day, 91 people die across the country from an opioid-related overdose and over 1,000
patients are administered emergency treatment for misusing opioids. Many others are swept into a cycle of
addiction and abuse with which they will struggle their entire lives. As many as 1 in 4 patients who receive
prescription opioids long-term for chronic pain in primary care settings
struggle with addiction. In 2014, almost
2 million Americans were addicted to prescription opioids and another 600,000
to heroin. From
1999 to 2015, more than 194,000 people died in the U.S. from overdoses related
to prescription opioids—more than the number of Americans who died in
the Vietnam War.

28.
The
outcomes in New Jersey, including Newark, are equally catastrophic—and getting
worse. The majority of overdose deaths
in Newark in 2017 are attributable to prescription or illicit opioids, and
overdoses are a major contributing factor to rising criminal activity in
Newark. New Jersey authorities have
recognized that the state faces an urgent public health crisis that requires
immediate action. Overdoses and
addiction have driven crime in the City and first responders are armed with
Narcan as a matter of course, at City expense.

29.
While
opioids have been diverted through illicit prescribing and sales, it is the
regular, legitimate prescribing of opioids that created and fueled this crisis. A study of 254 accidental opioid overdose
deaths in Utah found that 92% had been receiving prescriptions from health care
providers for chronic pain. Sales to
patients who doctor-shop (or visit multiple doctors to hide illicit or
over-use) constitute approximately only 1% of opioid volume.

31.
Accordingly,
the City brings this action to hold Defendants accountable for their conduct;
and seeks disgorgement, restitution, abatement, damages, and any other
injunctive and equitable relief within this Court’s powers to redress and halt
these deceptive practices.

PARTIES

A. Plaintiff

32.
Newark
is the largest City in New Jersey and the seat of Essex County. The City provides many services for its
residents, including public health, public assistance, and law enforcement services,
emergency care, and services for families and children. The City is also self-insured with respect to
workers’ compensation.

33.
The City
brings this action on its own behalf and as parens
patriae in the public interest.

B. Defendants

34.
Purdue
Pharma, L.P. is a limited partnership organized under the laws of
Delaware. Purdue Pharma, Inc. is a New Jersey
corporation with its principal place of business in Stamford, Connecticut. The Purdue Frederick Company is a Delaware
corporation with its principal place of business in Stamford, Connecticut.

35.
Purdue
manufactures, promotes, sells, and distributes opioids such as OxyContin, MS
Contin, Dilaudid and Dilaudid-HP, Butrans, Hysingla ER in the United States and
in Newark.[5]
OxyContin is Purdue’s best-selling
opioid: since 2009, Purdue’s annual sales of OxyContin have fluctuated between
$2 and $3 billion. Nationwide, OxyContin
constitutes roughly 25% of the entire market, by spending, for prescription
opioids.

36.
Teva
Pharmaceuticals USA, Inc. is a wholly-owned subsidiary of Teva Ltd. and is a
Delaware corporation with its principal place of business in Pennsylvania.
Teva USA acquired Cephalon in October 2011.
Cephalon, Inc. is a Delaware corporation with its principal place of
business in Frazer, Pennsylvania.
Teva Ltd., Teva USA, and Cephalon, Inc. work together closely to market
and sell Cephalon products in the United States. Teva Ltd. conducts all sales
and marketing activities for Cephalon in the United States through Teva
USA and has done so since its October 2011.
Teva Ltd. and Teva USA also sell generic opioids in the United States
and Newark, including generic opioids previously sold by Allergan plc, whose
generics business Teva Ltd. acquired in August 2016. Cephalon, Inc.
manufactures, promotes, sells, and distributes opioids such as Actiq and
Fentora in the U.S. and Newark. Actiq
and Fentora have been approved by the FDA only for the “management of breakthrough
cancer pain in patients 16 years of age and older who are already receiving
and who are tolerant to opioid therapy for their underlying persistent cancer
pain.” In 2008, Cephalon pled guilty to
a criminal violation of the Federal Food, Drug and Cosmetic Act for its
misleading promotion of Actiq and two other drugs and agreed to pay $425
million.

37.
Janssen
Pharmaceuticals, Inc. is a Pennsylvania corporation with its principal place of
business in Titusville, New Jersey, and is a wholly owned subsidiary of Johnson
& Johnson (J&J), a New Jersey corporation with its principal place of
business in New Brunswick, New Jersey.
Ortho-McNeil-Janssen Pharmaceuticals, Inc., now known as Janssen
Pharmaceuticals, Inc., is a Pennsylvania corporation with its principal place
of business in Titusville, New Jersey. Janssen Pharmaceutica Inc., now known as
Janssen Pharmaceuticals, Inc., is a Pennsylvania corporation with its principal
place of business in Titusville, New Jersey. J&J is the only company that
owns more than 10% of Janssen Pharmaceuticals’ stock, and corresponds with the FDA
regarding Janssen’s products. Upon information and belief, J&J controls the
sale and development of Janssen Pharmaceuticals’ drugs and Janssen’s profits inure to J&J’s benefit. (Janssen
Pharmaceuticals, Inc., Ortho-McNeil-Janssen Pharmaceuticals, Inc., Janssen
Pharmaceutica, Inc., and J&J are referred to as “Janssen.”).

38.
Janssen
manufactures, promotes, sells, and distributes drugs in the U.S. and Newark, including the opioid Duragesic. Before
2009, Duragesic accounted for at least $1 billion in annual sales. Until
January 2015, Janssen developed, marketed, and sold the opioids Nucynta and
Nucynta ER. Together, Nucynta and Nucynta ER accounted for $172 million in
sales in 2014.

39.
Endo
Health Solutions Inc. is a Delaware corporation with its principal place of
business in Malvern, Pennsylvania. Endo
Pharmaceuticals Inc. is a wholly-owned subsidiary of Endo Health Solutions Inc.
and is a Delaware corporation with its principal place of business in Malvern,
Pennsylvania. (Endo Health Solutions Inc. and Endo Pharmaceuticals Inc. are
referred to as “Endo.”)

40.
Endo
develops, markets, and sells prescription drugs, including the opioids
Opana/Opana ER, Percodan, Percocet, and Zydone, in the U.S. and Newark.
Opioids made up roughly $403
million of Endo’s overall revenues of $3 billion in 2012. Opana ER yielded
$1.15 billion in revenue from 2010 and 2013, and it accounted for 10% of Endo’s
total revenue in 2012. Endo also manufactures and sells generic opioids such as
oxycodone, oxymorphone, hydromorphone, and hydrocodone products in the U.S. and
Newark, by itself and through its subsidiary, Qualitest Pharmaceuticals, Inc.

JURISDICTION
AND VENUE

41.
Jurisdiction
over the subject matter of this action is proper in this Court, which has
original general jurisdiction throughout the State in all causes under N.J.
Stat. And. Const. Art. 6, § 3, ¶ 2.

42.
Defendants
are subject to personal jurisdiction in this Court, and venue is proper because
the cause of action arose in Essex County and because a party to the action is
located in Essex County. See N.J. Ct. R. R. 4:3-2(A).

ADDITIONAL
ALLEGATIONS COMMON TO ALL COUNTS

43.
Until
the mid-1990s, opioids were widely thought to be too addictive for use for
chronic pain conditions, which would require long-term use of the drugs at
increasingly high dose. For these
conditions, the risks of addiction and other side effects outweighed any
benefit from the drugs. For the last two
decades, Defendants have sought successfully to turn that consensus on its head,
primarily by covering up the risk of addiction and overstating the benefits of
using opioids long-term.

44.
Through
marketing that was as pervasive as it was deceptive, Purdue, Endo, Cephalon,
and Janssen convinced health care providers and consumers both that the risks
of long-term opioid use were overblown and that the benefits, in reduced pain
and improved function and quality of life, were proven.

45.
The
result was that by the mid-2000s, the medical community had abandoned its prior
caution, and opioids were entrenched as an appropriate—and often the first—treatment
for chronic pain conditions. Defendants
not only marketed opioids for chronic pain conditions, but targeted primary
care physicians (along with nurse practitioners and physician assistants), who
were most likely to see patients with chronic pain conditions and least likely
to have the training and experience to evaluate both Defendants’ marketing and
patients’ pain conditions.

46.
Thus,
Defendants’ deceptive marketing created a cadre of doctors who looked for pain
and treated it with opioids, which created an even broader cohort of patients
who expected and required opioids. This laid
the groundwork for today’s epidemic of opioid addiction, injury, and
death.

47.
Defendants
relied heavily on their sales representatives to convey their marketing
messages and materials to prescribers in targeted, in-person settings. Defendants developed national, company-wide
marketing strategies, which, upon information and belief based on this
large-scale strategy and uniformity of messaging, were applied throughout New
Jersey, including in Newark and the surrounding areas.

48.
To
ensure that sales representatives delivered the desired messages to
prescribers, Purdue, Endo, Cephalon, and Janssen directed and monitored their
respective sales representatives through detailed action plans, trainings,
tests, scripts, role-plays, supervisor tag-alongs, and review of
representatives’ “call notes” from each visit.
These Defendants likewise required their sales representatives to use
sales aids reviewed, approved, and supplied by the companies and forbade them
to use promotional materials not approved by the company’s marketing and
compliance departments. They further
ensured marketing consistency nationwide through national and regional sales
representative training. Thus, Defendants’
sales forces in New Jersey used the same deceptive messages about the risks and
benefits of its opioids that the companies employed nationwide.

Minimizing
or mischaracterizing the risk of addiction

49.
To
convince prescribers and patients that opioids are safe, Defendants deceptively
represented that the risk of abuse and addiction is modest and manageable and
limited to illegitimate patients, not those with genuine pain. This created the dangerously misleading
impressions that: (1) patients receiving
opioid prescriptions for chronic pain would not become addicted, (2) patients
at greatest risk of addiction could be identified, (3) all other patients could
safely be prescribed opioids, and (4) even high-risk patients could be
prescribed opioids if closely managed.

50.
Defendants’
sales representatives regularly omitted from their sales conversations with
prescribers any discussion of the risk of addiction from long-term use of
opioids. These omissions rendered other arguably truthful statements about
opioids false and misleading, and they both reinforced and failed to correct their
prior misrepresentations regarding the risk of addiction.

51.
Defendants
also deceptively undermined evidence that opioids are addictive by suggesting
or stating that the risk of addiction is limited to specific, high-risk
patients. According to Defendants, doctors
can screen patients to identify those who are likely to become addicted, and therefore
could safely prescribe to everyone else.
Defendants discounted general concerns or warnings regarding addiction
by reassuring doctors that their patients would not become addicted. One former Purdue sales representative in
another region confirmed Purdue’s message that opioids were appropriate and
safely prescribed to legitimate patients with actual pain; upon information and
belief, based on the uniformity of Purdue’s practices, the same message was
delivered to prescribers in the City. These
assurances were false and unsafe, as prescribers cannot accurately predict
which patients are at higher risk of addiction.
In addition, Defendants’ sales representatives also failed to disclose
to prescribers the difficulty of withdrawing from opioids. Discontinuing or delaying opioids can cause
intense physical and psychological effects, including anxiety, nausea,
headaches, and delirium, among others. This
difficulty in terminating use is a material risk, which can leave many patients
unwilling or unable to give up opioids and heightens the risk of
addiction.

52.
Promotional
materials and other publications disseminated or made available by Defendants
in the City have included similar messages minimizing the risk of
addiction.

53.
In
addition to deceptively ascribing signs of addiction to pseudoaddiction, as described
in Section B below, Defendants falsely portrayed
“true” addiction in its narrowest form. Providing Relief, Preventing Abuse, a
pamphlet published by Purdue in 2011 for prescribers and law enforcement, shows
pictures of the signs of injecting or snorting opioids—skin popping, track marks,
and perforated nasal septa—under the heading “Indications of Possible Drug
Abuse.” Purdue knew that opioid addicts
who resort to these extremes are uncommon; they far more typically become
dependent and addicted through oral use.
According to briefing materials Purdue
submitted to the FDA in October 2010, OxyContin was used non-medically by
injection as little as 4% of the time.

54.
These
depictions misleadingly reassured doctors that, in the absence of those extreme
signs, they need not worry that their patients are abusing or addicted to
opioids. Purdue made Providing Relief, Preventing Abuse available
to sales representatives to show to or leave with prescribers, including, on
information and belief, prescribers in the City.

55.
Purdue
also disseminated misleading information about opioids and addiction to
consumers and prescribers through the American Pain Foundation (“APF”). Purdue was APF’s second-biggest donor. Purdue grant letters informed APF that Purdue’s
contributions reflected the company’s effort to “strategically align its
investments in nonprofit organizations that share [its] business interests.” Purdue also engaged APF as a paid consultant
on various initiatives and deployed APF to lobby for its interests on Capitol
Hill.

56.
A Policymaker’s Guide to Understanding
Pain & Its Management, a Purdue-sponsored 2011 APF publication,
claimed that pain generally had been “undertreated” due to “[m]isconceptions about
opioid addiction.” This guide also
asserted, without basis, that “less than 1% of children treated with opioids
become addicted” and perpetuated the concept of pseudoaddiction. Purdue provided substantial funding in the
form of a $26,000 grant to APF and closely collaborated with APF in creating A Policymaker’s Guide. On information and belief, based on Purdue’s
close relationship with APF and the periodic reports APF provided to Purdue
about the project, Purdue had editorial input into A Policymaker’s Guide. It is
still available to City prescribers and consumers online.[6]

57.
Purdue
also maintained a website from 2008 to 2015, In the Face of Pain, that marketed directly to consumers and downplayed
the risks of chronic opioid therapy.
Purdue deactivated this website in October 2015 following an
investigation by the New York Attorney General. Although the site included the Purdue copyright
at the bottom of each page, the site did not refer to any specific Purdue
products and cultivated the “impression that it [was] neutral and unbiased.”[7]

58.
In the Face of Pain asserted that policies limiting access to
opioids are “at odds with best medical practices” and encouraged patients to be
“persistent” in finding doctors who will treat their pain. While a document linked from the website
briefly mentioned opioid abuse, the site itself never mentioned the risk of addiction. At the same time, the website contained
testimonials from several dozen physician “advocates” speaking positively about
opioids. Eleven of these advocates
received a total of $231,000 in payments from Purdue from 2008 to 2013—a fact
notably omitted from the site.[8]

59.
Endo
sponsored a website, Painknowledge.com, which claimed in 2009 that “[p]eople
who take opioids as prescribed usually do not become addicted.” Another Endo
website, PainAction.com, stated “Did you know? Most chronic pain patients do
not become addicted to the opioid medications that are prescribed for them.”
This website was still available online and available to consumers after May
21, 2011.

60.
Endo
distributed a pamphlet to consumers with the Endo logo entitled Living with
Someone with Chronic Pain, which counseled:
“Most health care providers who treat people with pain agree that most
people do not develop an addiction problem.” A similar statement appeared on
the Endo website www.opana.com.

61.
Janssen
reviewed, edited, approved, and distributed a patient education guide entitled Finding
Relief: Pain Management for Older Adults (2009), which described as “myth”
the claim that opioids are addictive, and asserted as fact that “[m]any studies
show that opioids are rarely addictive when used properly for the
management of chronic pain.” This guide
is still available online.

62.
Janssen
currently runs a website, Prescriberesponsibly.com, which claims that
concerns about opioid addiction are “overestimated.”

63.
Defendants’
efforts to trivialize the risk of addiction were, and remain, at odds with the
scientific evidence. Studies have shown
that at least 8-12%, and as many as 30-40% of long-term users of opioids
experience problems with addiction. In
March 2016, the FDA emphasized the “known serious risk[] of . . .
addiction”—“even at recommended doses” —of all opioids.”[9] That same month, after a “systematic review
of the best available evidence” by a panel excluding experts with conflicts of
interest, the CDC published the CDC Guideline for prescribing opioids for
chronic pain. The CDC Guideline noted that “[o]pioid pain
medication use presents serious risks, including overdose and opioid use
disorder” (a diagnostic term for addiction).[10] The CDC also emphasized that “continuing
opioid therapy for 3 months substantially increases risk for opioid use
disorder.”[11]

Overstating
the efficacy of screening tools

64.
Defendants
falsely instructed prescribers and patients that addiction risk screening
tools, patient contracts, urine drug screens, and similar strategies allow health
care providers to safely prescribe opioids to patients, including patients
predisposed to addiction, and failed to disclose the lack of evidence that
these strategies will mitigate addiction risk.

65.
Such
misrepresentations regarding safe opioid prescribing made health care providers
more comfortable prescribing opioids to their patients, and patients more
comfortable starting chronic opioid therapy.
These misrepresentations were especially insidious because Defendants aimed
them at general practitioners and family doctors who lack the time and
expertise to closely manage higher-risk patients on opioids. Moreover, these misrepresentations falsely reassured
doctors and patients that opioid addiction could be attributed to other
prescribers who failed to rigorously manage and weed out problem patients.

66.
Defendants
conveyed these safe prescribing messages through in-person sales calls to
doctors. Former Purdue sales
representatives claimed, including, upon information and belief, based on their
use elsewhere, to prescribers in the City, that doctors could screen out
patients at high risk of addiction through urine tests and patient contracts,
and that doctors could mitigate risk by prescribing only to trusted patients.[12]

67.
On
information and belief, based on their use elsewhere, Purdue sales
representatives in the City also shared the Partners
Against Pain “Pain Management Kit,” which contained several “drug abuse
screening tools.” These included the
“Opioid Risk Tool,” which is a five question, one-minute screening tool that
relies on patient self-reporting to identify whether there is a personal
history of substance abuse, sexual abuse, or “psychological disease,” ignoring
the sensitivity of the topic and the nature of addiction, which make it
unlikely that many patients can be counted on to share this information.

68.
Defendants
also promoted screening tools as a reliable means to manage addiction risk in
CME programs and scientific conferences, which likely were attended by and were
available to City prescribers.

70.
Purdue
also funded a 2012 CME program called Chronic
Pain Management and Opioid Use: Easing
Fears, Managing Risks, and Improving Outcomes. The presentation deceptively instructed
doctors that, through the use of screening tools, more frequent refills, and
other techniques, high-risk patients showing signs of addictive behavior could
be treated with opioids.

71. Purdue used its involvement in the
College on the Problems of Drug Dependence (“CPDD”), which promotes scientific
research and professional development to support addiction prevention
professionals, to promote the idea that addiction risk can be managed. A Purdue employee served on the CPDD board of
directors. Purdue presented an outsized
number of talks—with very different messages from non-Purdue talks—at each CPDD
conference. One of Purdue’s consistent
themes is that “bad apple” patients, not opioids, are the source of the
addiction crisis, and that once those patients are identified doctors can
safely prescribe opioids without addicting patients. Hundreds of addiction treatment specialists
from across the country and, upon information and belief, the City, attended
these conferences.

72. Endo paid for a 2007 supplement in the Journal
of Family Practice written by a doctor who became a member of Endo’s
speakers bureau in 2010. The supplement, entitled Pain Management Dilemmas
in Primary Care: Use of Opioids, emphasized the effectiveness of screening
tools, claiming that patients at high risk of addiction could safely receive
chronic opioid therapy using a “maximally structured approach” involving
toxicology screens and pill counts.

73.
A
2011 non-credit educational program sponsored by Endo, entitled Persistent Pain in the Older Adult,
claimed that withdrawal symptoms, which make it difficult for patients to stop
using opioids, can be avoided by tapering a patient’s opioid dose by 10%-20%
for 10 days.

74.
The
CDC Guideline confirms the falsity of Defendants’ claims about the utility of
patient screening and management strategies in managing addiction risk. The Guideline notes that there are no studies
assessing the effectiveness of risk mitigation strategies—such as screening
tools or patient contracts—“for improving outcomes related to overdose, addiction,
abuse, or misuse.” The CDC Guideline
recognizes that available risk screening tools “show insufficient accuracy for classification of patients as at low or
high risk for [opioid] abuse or misuse” and counsels that doctors “should not
overestimate the ability of these tools to rule out risks from long-term opioid
therapy.”[13]

B.
DEFENDANTS
FALSELY DESCRIBED ADDICTION AS PSEUDOADDICTION, AND DANGEROUSLY ENCOURAGED
DOCTORS TO RESPOND BY PRESCRIBING MORE OPIOIDS.

75.
Defendants
deceptively advised doctors to ignore signs of addiction as the product of an
unfounded condition it called pseudoaddiction.
Pseudoaddiction was a concept invented to convey the idea that signs of
addiction, including shopping for doctors willing to newly write or refill
prescriptions for opioids or seeking early refills, actually reflected
undertreated pain that should be addressed with more opioids—the medical
equivalent of fighting fire by adding fuel.

76.
Purdue,
through its unbranded imprint Partners Against
Pain,[14] promoted pseudoaddiction through at
least 2013 on its website.

77.
The
Federation of State Medical Boards (“FSMB”), a trade organization representing New
Jersey’s state medical board as well as others, finances opioid- and
pain-specific programs through grants from Purdue and other pharmaceutical
manufacturers. A 2004 version of the
FSMB Model Guidelines for the Use of
Controlled Substances for the Treatment of Pain (“FSMB Guidelines”), and
the 2007 book adapted from them, Responsible
Opioid Prescribing, advanced the concept of “pseudoaddiction.”

78.
Responsible
Opioid Prescribing was sponsored by Purdue and other opioid manufacturers. The FSMB website described the book as the
“leading continuing medical education (CME) activity for prescribers of opioid
medications.” In all, more than 163,000
copies of Responsible Opioid Prescribing
were distributed nationally.

79.
Janssen
sponsored, funded, and edited the Let’s Talk Pain website, which in 2009 stated: “pseudoaddiction
. . . refers to patient behaviors that may occur when pain is under-treated
. . . . Pseudoaddiction is different
from true addiction because such behaviors can be resolved with
effective pain management.” This website was accessible online until May 2012.

80.
Endo
sponsored a National Initiative on Pain Control (NIPC) CME program in 2009
titled Chronic Opioid Therapy:
Understanding Risk While Maximizing Analgesia, which promoted
pseudoaddiction by teaching that a patient’s aberrant behavior was the result
of untreated pain. Endo substantially controlled NIPC by funding NIPC projects;
developing, specifying, and reviewing content; and distributing NIPC materials.

82.
The
CDC Guideline rejects the concept of pseudoaddiction. The Guideline nowhere recommends that
prescribers increase opioid doses if a patient is not experiencing pain
relief. To the contrary, the Guideline
explains that “[p]atients who do not experience clinically meaningful pain
relief early in treatment . . . are unlikely to experience pain relief with
longer-term use,”[15]
and that physicians should “reassess[] pain and function within 1 month” in
order to decide whether to “minimize risks of long-term opioid use by
discontinuing opioids” because the patient is “not receiving a clear benefit.”[16]

C.
DEFENDANTS OVERSTATED THE BENEFITS OF CHRONIC
OPIOID THERAPY WHILE FAILING TO DISCLOSE THE LACK OF EVIDENCE SUPPORTING
LONG-TERM USE

1.
Mischaracterizing the benefits of long-term use

83.
To
convince prescribers and patients that opioids were appropriate to treat
chronic pain, Defendants had to persuade them of a significant upside to
long-term opioid use. But as the CDC
Guideline makes clear, there is “insufficient
evidence to determine the long-term benefits of opioid therapy for chronic
pain.”[17] In fact, the CDC found that “[n]o evidence
shows a long-term benefit of opioids in pain and function versus no opioids for
chronic pain with outcomes examined at least 1 year later (with most
placebo-controlled randomized trials ≤ 6 weeks in duration)”[18] and that other treatments were more or
equally beneficial and less harmful than long-term opioid use. The FDA, too,
has recognized the lack of evidence to support long-term opioid use. In 2013,
the FDA stated that it was “not aware of adequate and well-controlled studies
of opioids use longer than 12 weeks.”[19] As a result, the CDC recommends that opioids
be used not in the first instance and only after prescribers have exhausted
alternative treatments.

84.
Nevertheless,
upon information and belief, Defendants touted the purported benefits of
long-term opioid use, while falsely and misleadingly suggesting that these
benefits were supported by scientific evidence.

85.
Two prominent
professional medical membership organizations, the American Pain Society
(“APS”) and the American Academy of Pain Medicine (“AAPM”), each received
substantial funding from Purdue. Upon
information and belief, Defendants exercised considerable influence over their
work on opioids. Both organizations
issued a consensus statement in 1997, The
Use of Opioids for the Treatment of Chronic Pain, that endorsed opioids to
treat chronic pain and claimed that the risk that patients would become
addicted to opioids was low. The
co-author of the statement, Dr. David Haddox, was at the time a paid speaker
for Purdue and later became a senior executive for the company. Dr. Portenoy, a pain management specialist
who received Purdue research grants and was a Purdue consultant, was the sole
consultant. The consensus statement
remained on AAPM’s website until 2011.
The statement was taken down from AAPM’s website only after a doctor
complained.

86.
AAPM
and APS issued treatment guidelines in 2009 (“AAPM/APS Guidelines”) which
continued to recommend the use of opioids to treat chronic pain. Treatment guidelines, like the AAPM/APS
Guidelines, were particularly important to Defendants in securing acceptance
for chronic opioid therapy. They are
relied upon by doctors, especially general practitioners and family doctors who
have no specific training in treating chronic pain. Six of the twenty-one panel members who
drafted the AAPM/APS Guidelines received support from Purdue, eight from Teva,
nine from Janssen, and ten from Endo.

87.
The
AAPM/APS Guidelines promote opioids as “safe and effective” for treating chronic
pain. The panel made “strong
recommendations” despite “low quality of evidence” and concluded that the risk
of addiction is manageable for patients, even with a prior history of drug
abuse. One panel member, Dr. Joel Saper,
Clinical Professor of Neurology at Michigan State University and founder of the
Michigan Headache & Neurological Institute, resigned from the panel because
of his concerns that the Guidelines were influenced by contributions that drug
companies, including Purdue, Endo, Janssen, and Teva made to the sponsoring
organizations and committee members.

88.
Dr.
Gilbert Fanciullo, a retired professor at Dartmouth College’s Geisel School of
Medicine who served on the AAPM/APS Guidelines panel, has since described them
as “skewed” by drug companies and “biased in many important respects,”
including its high presumptive maximum dose, lack of suggested mandatory urine
toxicology testing, and claims of a low risk of addiction.

89.
The
AAPM/APS Guidelines are still available online, were reprinted in the Journal of Pain, have been a
particularly effective channel of deception, and have influenced not only
treating physicians, but also the body of scientific evidence on opioids. According to Google Scholar, they have now
been cited at least 1,647 times in academic literature.

90.
Defendants
also published misleading studies to enhance the perception that opioids are
effective long-term for chronic pain conditions. One study asserts that OxyContin is safe and
effective for the chronic pain condition osteoarthritis. The study, sponsored by Purdue, involved
providing oxycodone for 30 days, and then randomizing participants and
providing a placebo, IR oxycodone with acetaminophen (like Percocet), or
OxyContin. Only 107 of the 167 patients
went on to the second phase of the study, and most who withdrew left because of
adverse events (nausea, vomiting, drowsiness, dizziness, or headache) or
ineffective treatment. Despite relating to a chronic condition, opioids were
provided only short-term. The authors
even acknowledge that the “results… should be confirmed in trials of longer
duration to confirm the role of opioids in a chronic condition such as OA
[osteoarthritis].”[20]
Yet, the authors conclude that “[t]his clinical experience shows that
opioids were well tolerated with only rare incidence of addiction and that
tolerance to the analgesic effects was not a clinically significant problem
when managing patients with opioids long-term.”[21]
This statement is not supported by the data—a substantial number of
patients dropped out because of adverse effects, there was no reported data
regarding addiction, and the study was not long-term.

91.
Cephalon
deceptively marketed its opioids Actiq and Fentora for chronic pain even though
the FDA has expressly limited their use to the treatment of cancer pain in
opioid-tolerant individuals.

92.
Both
Actiq and Fentora are extremely powerful fentanyl-based IR opioids. Neither is approved
for or has been shown to be safe or effective for chronic pain. Indeed, the FDA
expressly prohibited Cephalon from marketing Actiq for anything but cancer
pain, and refused to approve Fentora for the treatment of chronic pain because
of the potential harm, including the high risk of “serious and life-threatening
adverse events” and abuse – which are greatest in non-cancer patients.
The FDA also issued a Public Health Advisory in 2007 emphasizing that Fentora
should only be used for cancer patients who are opioid-tolerant and should
not be used for any other conditions, such as migraines, post-operative pain,
or pain due to injury.

93.
Despite
this, Cephalon conducted and continues to conduct a well-funded
campaign to promote Actiq and Fentora for chronic pain and other
non-cancer conditions for which it was not approved, appropriate, or safe. As
part of this campaign, Cephalon used CMEs, speaker programs, KOLs, journal
supplements, and detailing by its sales representatives to give doctors and
consumers the false impression that Actiq and Fentora are safe and effective
for treating non-cancer pain.

94.
For
example: Cephalon paid to have a CME it sponsored, Opioid-Based Management of
Persistent and Breakthrough Pain, published in a supplement of Pain
Medicine News in 2009. The CME instructed doctors that “clinically, broad
classification of pain syndromes as either cancer- or noncancer-related has
limited utility” and recommended Actiq and Fentora for patients with chronic
pain. The CME is still available online.

95.
Cephalon’s
sales representatives set up hundreds of speaker programs for doctors, including
many non-oncologists, which promoted Actiq and Fentora for the treatment of
non-cancer pain.

96.
In December 2011, Cephalon widely disseminated
a journal supplement entitled “Special Report: An Integrated Risk Evaluation
and Mitigation Strategy for Fentanyl Buccal Tablet (FENTORA) and Oral
Transmucosal Fentanyl Citrate (ACTIQ)” to Anesthesiology News, Clinical
Oncology News, and Pain Medicine News – three publications that are sent
to thousands of anesthesiologists and other medical professionals. The Special
Report openly promotes Fentora for “multiple causes of pain” – and not just
cancer pain.

97.
Cephalon’s
deceptive marketing gave doctors and patients the false impression that Actiq
and Fentora were not only safe and effective for treating chronic pain, but
were also approved by the FDA for such uses.

98.
On December 28, 2011, the FDA mandated a Risk
Evaluation and Mitigation Strategy (REMS) for the class of products for which
Teva’s Actiq and Fentora belong, Transmucosal Immediate Release Fentanyl
(TIRF). The TIRF REMS programs include
mandatory patient and prescriber enrollment forms, as well as certification
requirements for prescribers. The forms
are not totally comprehensive and do not, for instance, disclose that addiction
can develop when prescribed as directed, nor do they disclose that risks are
greatest at higher doses—and patients must already be taking high doses of
opioids to be prescribed Actiq and Fentora.

Overstating
opioids’ effect on patients’ function and quality of life

99.
Defendants
also claimed—without evidence—that long-term opioid use would help patients
resume their lives and jobs. On
information and belief, sales representatives promoted the ability of opioids to
improve patients’ function and quality of life.

100.
Defendants’
and Defendant-sponsored materials that, upon information and believe, were distributed
or made available in the City reinforced this message. The 2011 publication A Policymaker’s Guide falsely claimed that “multiple clinical
studies have shown that opioids are effective in improving daily function and
quality of life for chronic pain patients.”
A series of medical journal advertisements for OxyContin in 2012
presented “Pain Vignettes”—case studies featuring patients with pain conditions
persisting over several months—that implied functional improvement. For example, one advertisement described a
“writer with osteoarthritis of the hands” and implied that OxyContin would help
him work more effectively. Since at
least May 21, 2011, Endo has distributed and made available on its website
opana.com a pamphlet promoting Opana ER with photographs depicting patients
with physically demanding jobs like construction worker and chef, misleadingly
implying that the drug would provide long-term pain-relief and functional
improvement. Additional illustrative
examples are described below:

a. Janssen sponsored and edited a patient
education guide entitled Finding Relief:
Pain Management for Older Adults (2009) – which states as “a fact” that
“opioids may make it easier for
people to live normally.” The guide lists expected functional improvements from
opioid use, including sleeping through the night, returning to work,
recreation, sex, walking, and climbing stairs and states that “[u]sed properly,
opioid medications can make it possible for people with chronic pain to ‘return
to normal.’” This guide was still available after May 21, 2011.

b. Purdue ran a series of advertisements for
OxyContin in 2012 in medical journals entitled “Pain vignettes,” which were
case studies featuring patients with pain conditions persisting over several
months and recommending OxyContin for them. The ads implied that OxyContin
improves patients’ function.

c. Responsible
Opioid Prescribing (2007), sponsored and distributed by
Cephalon, Endo and Purdue, taught that relief of pain by opioids, by itself,
improved patients’ function. The book remains for sale online.

d. Purdue and Cephalon sponsored APF’s Treatment Options: A Guide for People Living
with Pain (2007), which counseled patients that opioids “give [pain
patients] a quality of life we deserve.” The guide was available online until
APF shut its doors in May 2012.

e. Endo’s NIPC website painknowledge.com claimed in 2009 that with opioids, “your level of
function should improve; you may find you are now able to participate in
activities of daily living, such as work and hobbies, that you were not able to
enjoy when your pain was worse.” Elsewhere, the website touted improved quality
of life (as well as “improved function”) as benefits of opioid therapy. The
grant request that Endo approved for this project specifically indicated NIPC’s
intent to make misleading claims about function, and Endo closely tracked
visits to the site.

f. Endo was the sole sponsor, through NIPC,
of a series of CMEs titled Persistent
Pain in the Older Patient, which claimed that chronic opioid therapy has
been “shown to reduce pain and improve depressive symptoms and cognitive functioning.”
The CME was disseminated via webcast.

101.
Likewise,
Defendants’ claims that long-term use of opioids improves patient function and
quality of life are unsupported by clinical evidence. There are no controlled studies of the use of
opioids beyond 16 weeks, and there is no evidence that opioids improve
patients’ pain and function long-term.
On the contrary, the available evidence indicates opioids are not
effective to treat chronic pain, and may worsen patients’ health and pain. Increasing the duration of opioid use is
strongly associated with an increasing prevalence of mental health conditions
(depression, anxiety, post-traumatic stress disorder, and substance abuse),
increased psychological distress, and greater health care utilization.

102.
As
one pain specialist observed, “opioids may work acceptably well for a while,
but over the long term, function generally declines, as does general health,
mental health, and social functioning.
Over time, even high doses of potent opioids often fail to control pain,
and these patients are unable to function normally.”[22]
Studies of patients with lower back pain and migraine headaches, for
example, have consistently shown that patients experienced deteriorating
function over time, as measured by ability to return to work, physical
activity, pain relief, rates of depression, and subjective quality-of-life
measures. Analyses of workers’
compensation claims have found that workers who take opioids are almost four
times more likely to reach costs over $100,000, stemming from greater side
effects and slower returns to work. According
to these studies, receiving an opioid for more than seven days also increased
patients’ risk of being on work disability one year later.

103.
Assessing
existing science, the CDC Guideline found that there was “[n]o evidence
show[ing] a long-term benefit of opioids in pain and function versus no opioids
for chronic pain with outcomes examined at least 1 year later”[23] and advised that “there is no good
evidence that opioids improve pain or function with long-term use.”[24] The
FDA and other federal agencies have made this clear for years. [25]
The CDC also noted that the risks of addiction and death “can cause
distress and inability to fulfill major role obligations.”[26] The
CDC Guideline concluded that “[w]hile benefits for pain relief, function and
quality of life with long-term opioid use for chronic pain are uncertain, risks
associated with long-term opioid use are clearer and significant.”[27]
According to the CDC, “for the vast majority of patients, the known,
serious, and too-often-fatal risks far outweigh the unproven and transient
benefits [of opioids for chronic pain].”[28]

Omitting or mischaracterizing
adverse effects of opioids

104.
In
materials Defendants produced, sponsored, or controlled, Defendants omitted
known risks of chronic opioid therapy and emphasized or exaggerated risks of
competing products so that prescribers and patients would be more likely to
choose opioids and would favor opioids over other therapies such as
over-the-counter acetaminophen or nonsteroidal anti-inflammatory drugs (or NSAIDs,
like ibuprofen). None of these claims
were corroborated by scientific evidence.

105.
In
addition to failing to disclose in promotional materials the risks of
addiction, abuse, overdose, and respiratory depression, Defendants routinely
ignored the risks of hyperalgesia, a “known serious risk associated with
chronic opioid analgesic therapy,”[29] in which the patient becomes more
sensitive to pain over time, hormonal dysfunction; decline in immune function;
mental clouding, confusion, and dizziness; increased falls and fractures in the
elderly; neonatal abstinence syndrome (when an infant exposed to opioids
prenatally withdraws from the drugs after birth); and potentially fatal
interactions with alcohol or benzodiazepines, which are used to treat
post-traumatic stress disorder and anxiety (often among veterans, for example, post-traumatic
stress disorder and anxiety also can accompany chronic pain symptoms).

106.
Purdue
and Cephalon sponsored APF’s Treatment
Options: A Guide for People Living with Pain (2007), which counseled
patients that opioids differ from NSAIDs in that they have “no ceiling dose”
and are therefore the most appropriate treatment for severe pain. The publication inaccurately attributes
10,000 to 20,000 deaths annually to NSAIDs (the actual figure is approximately
3,200, far fewer than from opioids).[30] This
publication also warned that risks of NSAIDs increase if “taken for more than a
period of months,” with no corresponding warning about opioids.

107.
Purdue
also sponsored APF’s Exit Wounds
(2009), a book aimed at veterans. This
book omits warnings of the potentially fatal risk of interactions between
opioids and benzodiazepines, a class of drug commonly prescribed to veterans
with post-traumatic stress disorder. This
book is available from Amazon.com and other retailers.

108.
Purdue
sponsored a CME program, Overview of
Management Options, published by the American Medical Association in 2003,
2007, 2010, and 2013, and discussed further below. The CME taught that NSAIDs and other drugs,
but not opioids, are unsafe at high doses.

110.
These
omissions are significant and material to patients and prescribers. A Cochrane Collaboration review of evidence
relating to the use of opioids for chronic pain found that 22% of patients in
opioid trials dropped out before the study began because of the “intolerable
effects” of opioids.[31]

111.
Again,
Defendants’ misrepresentations were effective.
A study of 7.8 million doctor visits nationwide between 2000 and 2010
found that opioid prescriptions increased from 11.3% to 19.6% of visits while
NSAID and acetaminophen prescriptions fell from 38% to 29%. The CDC reports that the quantity of opioids
dispensed per capita trebled from 1999 to 2015.

D.
DEFENDANTS CONTINUED TO TELL DOCTORS THAT
OPIOIDS COULD BE TAKEN IN EVER-HIGHER DOSES WITHOUT DISCLOSING THEIR GREATER
RISKS

112.
Defendants
falsely claimed to prescribers and consumers that opioids could be taken in
ever-increasing strengths to obtain pain relief, without disclosing that higher
doses increased the risk of addiction and overdose. This was particularly important because
patients on opioids for more than a brief period develop tolerance, requiring
increasingly high doses to achieve pain relief.
Defendants needed to generate this comfort level among doctors and
patients to ensure patients were maintained on the drugs. Further, as described in more detail in
Section E, Purdue encouraged doctors to prescribe
higher doses, rather than prescribe OxyContin more frequently than twice-a-day—despite
knowing that OxyContin frequently did not provide 12 hours of relief.

113.
Purdue-sponsored
publications and CMEs available in New Jersey also misleadingly suggested that
higher opioid doses carried no added risk.

114.
Through
at least June 2015, Purdue’s In the Face of Pain website promoted the
notion that if a patient’s doctor did not prescribe a sufficient dose of
opioids, the patient should see different doctors until finding a doctor who
would.

115.
A
Policymaker’s Guide, the 2011
publication on which, upon information and belief, Purdue collaborated with APF,
taught
that dose escalations are “sometimes necessary,” but did not disclose the risks
from high dose opioids. This publication
is still available online.[32]

116.
The
Purdue-sponsored CME, Overview of Management Options,
discussed above, again instructed physicians that NSAIDs (like ibuprofen) are
unsafe at high doses (because of risks to patients’ kidneys), but did not
disclose risks from opioids at high doses.

117.
Endo
sponsored a website, painknowledge.com, which claimed in 2009 that opioid dosages
may be increased until “you are on the right dose of medication for your pain.”

118.
Endo
distributed a pamphlet edited by Dr. Russell Portenoy entitled Understanding
Your Pain: Taking Oral Opioid Analgesics, which was still available after May 21, 2011 on Endo’s
website. In Q&A format, it asked “If I take the opioid now, will it work
later when I really need it?” The response is, “The dose can be increased. . .
. You won’t ‘run out’ of pain relief.”

120.
These
claims conflict with the scientific evidence.
Patients receiving high doses of opioids (e.g., doses greater than 100 mg morphine equivalent dose (“MED”) per
day) as part of long-term opioid therapy are three to nine times more likely to
suffer overdose from opioid-related causes than those on low doses.[33]
As compared to available alternative pain remedies, scholars have
suggested that tolerance to the respiratory depressive effects of opioids
develops at a slower rate than tolerance to opioids’ analgesic effects. Accordingly, the practice of continuously
escalating doses to match pain tolerance can, in fact, lead to overdose even
where opioids are taken as recommended.

121.
The
CDC Guideline concludes that the “[b]enefits of high-dose opioids for chronic
pain are not established” while “there is an increased risk for serious harms
related to long-term opioid therapy that appears to be dose-dependent.”[34]
That is why the CDC advises doctors to “avoid increasing doses” above 90
mg MED.[35]

E.
PURDUE MISLEADINGLY PROMOTED OXYCONTIN AS
SUPPLYING 12 HOURS OF PAIN RELIEF WHEN
PURDUE KNEW THAT, FOR MANY PATIENTS, IT DID NOT.

122.
To
convince prescribers and patients to use OxyContin, Purdue misleadingly
promoted the drug as providing 12 continuous hours of pain relief with each
dose. In reality, OxyContin does not
last for 12 hours in many patients, a fact Purdue has known since the product’s
launch. While OxyContin’s FDA-approved
label directs 12 hour dosing, Purdue sought that dosing frequency in order to
maintain a competitive advantage over more frequently dosed opioids. Yet Purdue has gone well beyond the label’s
instructions to take OxyContin every 12 hours by affirmatively claiming, in
their general marketing and upon information and belief, to prescribers in the City,
that OxyContin lasts for 12 hours, promoting 12-hour dosing as a key advantage
of OxyContin, and by failing to disclose that OxyContin fails to provide 12
hours of pain relief to many patients.

123.
These
misrepresentations, which Purdue continues to make, are particularly dangerous
because inadequate dosing helps fuel addiction, as explained below. Purdue conveyed to prescribers that the
solution to end-of-dose failure is not more frequent dosing but higher
doses—which pose greater risks, as discussed in Section D.

124.
OxyContin
has been FDA-approved for twice-daily—“Q12”—dosing frequency since its debut in
1996. Yet it was Purdue’s decision to
submit OxyContin for approval with 12-hour rather than 8-hour dosing.

125.
Under
FDA guidelines for establishing dosing, Purdue merely had to show that
OxyContin lasted for 12 hours for at least half of patients, and Purdue
submitted a single study that cleared that bar.
While the OxyContin label indicates that “[t]here are no well-controlled
clinical studies evaluating the safety and efficacy with dosing more frequently
than every 12 hours,” Purdue has conducted no such studies.

126.
From
the outset, Purdue leveraged 12-hour dosing to promote OxyContin as providing
continuous, round-the-clock pain relief with the convenience of not having to
wake to take a third or fourth pill. The
1996 press release for OxyContin touted 12-hour dosing as providing “smooth and
sustained pain control all day and all night.”
But the FDA has never approved such a marketing claim. To the contrary, the FDA found in 2008, in
response to a Citizen Petition by the Connecticut Attorney General, that a
“substantial number” of chronic pain patients taking OxyContin experienced “end
of dose failure”—i.e., little or no
pain relief at the end of the dosing period.

127.
Moreover,
Purdue itself long has known, dating to its development of OxyContin, that the
drug wears off well short of 12 hours in many patients. In one early Purdue clinical trial, a third
of patients dropped out because the treatment was ineffective. Researchers changed the rules to allow
patients to take supplemental painkillers—“rescue medication”—in between
OxyContin doses. In another study, most
patients used rescue medication, and 95% resorted to it at least once. In other research conducted by Purdue, the
drug wore off in under 6 hours in 25% of patients and in under 10 hours in more
than 50%.

128.
End-of-dose
failure renders OxyContin even more dangerous because patients begin to
experience distressing psychological and physical withdrawal symptoms, followed
by a euphoric rush with their next dose—a cycle that fuels a craving for
OxyContin. For this reason, Dr. Theodore
Cicero, a neuropharmacologist at the Washington University School of Medicine
in St. Louis, has called OxyContin’s 12-hour dosing “the perfect recipe for
addiction.”[36]Many patients will exacerbate this cycle
by taking their next dose ahead of schedule or resorting to a rescue dose of
another opioid, increasing the overall amount of opioids they are taking.

129.
Purdue
has remained committed to 12-hour dosing because it is key to OxyContin’s
market dominance and comparatively high price; without this advantage, the drug
had little to offer over less expensive, short-acting opioids. In a 2004 letter to the FDA, Purdue
acknowledged that it had not pursued approval to allow more frequent dosing in
the label (e.g., every 8 hours)
because 12-hour dosing was “a significant competitive advantage.”Purdue
also falsely promoted OxyContin as providing “steady state” relief, less likely
than other opioids to create a cycle of crash and cravings that fueled
addiction and abuse—a misrepresentation made upon information and belief, in Newark.

130.
Without
appropriate caveats, promotion of 12-hour dosing by itself is misleading
because it implies that the pain relief supplied by each dose lasts 12 hours,
which Purdue knew to be untrue for many, if not most, patients. FDA approval of OxyContin for 12-hour dosing
does not give Purdue license to misrepresent the duration of pain relief it
provides to patients; moreover, Purdue had a responsibility to correct its
label to reflect appropriate dosing, to disclose to prescribers what it knew
about OxyContin’s actual duration, and not to promote more dangerous higher
dosing, rather than increased frequency of use, regardless of any marketing
advantage.[37]

131.
Purdue
was also aware of some physicians’ practice of prescribing OxyContin more
frequently than 12 hours—a common occurrence.
Purdue’s promoted solution to this problem was to increase the dose,
rather than the frequency, of prescriptions, even though higher dosing carries
its own risks—including increased danger of addiction, overdose, and
death. It means that patients will
experience higher highs and lower lows, increasing their craving for their next
pill. Nationwide, based on an analysis
by the Los Angeles Times, more than
52% of patients taking OxyContin longer than three months are on doses greater
than 60 milligrams per day—which converts to the 90 milligrams of morphine
equivalent that the CDC Guideline urges prescribers to “avoid” or “carefully
justify.”[38]

132.
By
the mid-2000s, widespread addiction to and abuse of OxyContin had emerged in
the public eye. Rather than acknowledge
that these problems were the inevitable result of widespread prescribing of
OxyContin for chronic pain, Purdue claimed that abuse and addiction resulted
from diversion by abusers snorting or injecting the drugs. Purdue also brought to market an
“abuse-deterrent” formulation of OxyContin but deceptively marketed it to
doctors as a solution to the opioid epidemic.

133.
Reformulated,
ADF OxyContin was approved by the FDA in April 2010. However, the FDA noted that “the
tamper-resistant properties will have no effect on abuse by the oral route (the
most common mode of abuse).” It was not
until 2013 that the FDA, in response to a Citizen Petition filed by Purdue,
permitted reference to the abuse-deterrent properties in the label. When Hysingla ER (extended-release
hydrocodone) launched in 2014, the product included similar abuse-deterrent
properties.

134.
Purdue
sales representatives regularly used the so-called abuse-deterrent properties
of Purdue’s opioids as a primary selling point to differentiate those products
from their competitors, including, upon information and belief, in the City. Specifically, Purdue detailers:

a.
claimed that Purdue’s ADF opioids prevent tampering and that its AD products could not be crushed or
snorted.

c.
asserted or suggested that Purdue’s ADF opioids are
“safer” than other opioids.

d.
failed to disclose that Purdue’s ADF opioids do not
impact oral abuse or misuse.

135.
These
statements and omissions by Purdue are false and misleading and are
inconsistent with the FDA-approved labels for Purdue’s ADF opioids—which
indicate: that abusers seek them because
of their high likeability when snorted, that their abuse deterrent properties
can be defeated, and that they can be abused orally notwithstanding their abuse-deterrent
properties, and which do not indicate
that ADF opioids prevent or reduce abuse, misuse, or diversion.

136.
Purdue
knew or should have known that “reformulated OxyContin is not better at tamper
resistance than the original OxyContin”[39] and is still regularly tampered with and
abused. Websites and message boards used
by drug abusers, such as bluelight.org and reddit, report a variety of ways to
tamper with OxyContin and Hysingla ER, including through grinding, microwaving
then freezing, or drinking soda or fruit juice in which a tablet is dissolved. A publicly available Citizen Petition
submitted to the FDA in 2016 by a drug manufacturing firm challenged Purdue’s
abuse-deterrent labeling based on the firm’s ability to easily prepare
OxyContin to be snorted or injected.

137.
Further,
one-third of the patients in a 2015 study
defeated the ADF mechanism and were able to continue inhaling or injecting the
drug. To the extent that the abuse of
Purdue’s ADF opioids was reduced, those addicts simply shifted to other drugs
such as heroin.

138.
A
2013 article presented by Purdue employees based on review of data from poison
control centers, while concluding that ADF OxyContin can reduce abuse, ignored
important negative findings. The study
reveals that abuse merely shifted to other drugs and that, when the actual
incidence of harmful exposures was calculated, there were more harmful exposures to opioids (including heroin) after the
reformulation of OxyContin. In short,
the article emphasized the advantages and ignored the disadvantages of ADF OxyContin—reflecting
the same pattern of tilting scientific research and literature to support the
promotion of opioids discussed in Section IV.A.2.

139.
The
CDC Guideline confirms that “[n]o
studies” support the notion that “abuse-deterrent technologies [are] a risk
mitigation strategy for deterring or preventing abuse,” noting that the
technologies “do not prevent opioid abuse through oral intake, the most common
route of opioid abuse, and can still be abused by nonoral routes.”[40] Tom
Frieden, the Director of the CDC, reported that his staff could not find “any
evidence showing the updated opioids [ADF opioids] actually reduce rates of
addiction, overdoses, or death.” [41]

140.
In
2015, claiming a need to further assess its data, Purdue abruptly withdrew a
supplemental new drug application related to reformulated OxyContin one day
before FDA staff were to release its assessment of the application. The staff review preceded an FDA advisory
committee meeting related to new studies by Purdue “evaluating the misuse
and/or abuse of reformulated OxyContin” and whether those studies “have
demonstrated that the reformulated product has a meaningful impact on abuse.”[42] Upon
information and belief, Purdue never presented the data to the FDA because the data
would not have supported claims that OxyContin’s ADF properties reduced abuse
or misuse.

141.
Yet
despite the qualifying language in Purdue’s label and its own evidence—and lack
of evidence—regarding the impact of its ADF opioids in reducing abuse, Dr. J.
David Haddox, the Vice President of Health Policy for Purdue, falsely claimed
in 2016 that the evidence does not show that Purdue’s ADF opioids are being
abused in large numbers.

142.
Generic
versions of OxyContin, which became available in February 2011, threatened to
erode Purdue’s market share and the price it could charge. Through a Citizen Petition, Purdue was able
to secure a determination by the FDA in April 2013 that original OxyContin
should be removed from the market as unsafe (lacking abuse-deterrent properties),
and thus non-ADF generic copies could not be sold. As a result, Purdue extended its branded
exclusivity for OxyContin until the patent protection on the abuse-deterrent
coating expires.

143.
Purdue’s
false and misleading marketing of the benefits of its ADF opioids preserved and
expanded its sales by persuading doctors to write prescriptions for ADF opioids
in the mistaken belief that they were safer. It also allowed prescribers to discount
evidence of opioid addiction and abuse and attribute it to other, less safe
opioids—i.e., it allowed them to
believe that while patients might abuse, become addicted to, or die from other,
non-ADF opioids, Purdue’s opioids did not carry that risk.

144.
Endo
has marketed Opana ER as tamper- or crush-resistant and less prone to misuse
and abuse since at least May 21, 2011 even though: (1) the FDA rejected Endo’s
petition to approve Opana ER as abuse-deterrent in 2012; (2) the FDA warned in
a 2013 letter that there was no evidence that Opana ER “would provide a
reduction in oral, intranasal or intravenous abuse”; and (3) Endo’s own
studies, which it failed to disclose, showed that Opana ER could still be
ground and chewed. Endo’s advertisements
for the 2012 reformulation of Opana ER falsely claimed that it was designed to
be crush resistant, in a way that suggested it was more difficult to abuse. And since 2012, detailers for Endo have
informed doctors, including, upon information and belief, doctors in the City,
that Opana ER is harder to abuse. A
consumer survey further confirms several prescribers in the northeastern United
States confirming that Endo sales representatives promoted Opana ER as “crush
resistant.”

145.
In a
2016 settlement with Endo, the New York Attorney General (“NY AG”) found that statements
that Opana ER was “designed to be, or is crush resistant” were false and
misleading because there was no difference in the ability to extract the
narcotic from Opana ER. The NY AG also found that Endo failed to disclose its
own knowledge of the crushability of redesigned Opana ER in its marketing to
formulary committees and pharmacy benefit managers.

G.
PURDUE AND ENDO ALSO ENGAGED IN OTHER UNLAWFUL,
DECEPTIVE, AND UNFAIR CONDUCT BY FAILING TO REPORT SUSPICIOUS PRESCRIBING

146.
Purdue
deceptively and unfairly failed to report to New Jersey authorities illicit or
suspicious prescribing of its opioids, even as it has publicly and repeatedly
touted its “constructive role in the fight against opioid abuse,” including its
commitment to ADF opioids and its “strong record of coordination with law
enforcement.”[43]

147.
As
described in Section IV.A.1, Purdue’s public stance long has been that “bad
apple” patients and drug diversion to illicit secondary channels—and not
widespread prescribing of OxyContin and other opioids for chronic pain—are to
blame for widespread addiction and abuse.
To address the problems of illicit use and diversion, Purdue promotes
its funding of various drug abuse and diversion prevention programs and
introduction of ADF opioids. This allows
Purdue to present itself as a responsible corporate citizen while continuing to
profit from the commonplace prescribing of its drugs, even at high doses for
long-term use.

148.
At
the heart of Purdue’s public outreach is the claim that it works hand-in-glove
with law enforcement and government agencies to combat opioid abuse and
diversion. Purdue has consistently trumpeted
this partnership since at least 2008, and the message of close cooperation in
virtually all of Purdue’s recent pronouncements in response to the opioid abuse.

149.
Touting
the benefits of ADF opioids, Purdue’s website asserts: “[W]e are acutely aware of the public health
risks these powerful medications create . . . . That’s why we work with health
experts, law enforcement, and government agencies on efforts to reduce the
risks of opioid abuse and misuse . . . .”[44] Purdue’s statement on “Opioids Corporate Responsibility”
likewise states that “[f]or many years, Purdue has committed substantial
resources to combat opioid abuse by partnering with . . . communities, law
enforcement, and government.”[45]
And, responding to criticism of Purdue’s
failure to report suspicious prescribing to government regulatory and
enforcement authorities, the website similarly proclaims that Purdue “ha[s] a
long record of close coordination with the DEA and other law enforcement
stakeholders to detect and reduce drug diversion.”[46]

150.
These
public pronouncements create the misimpression that Purdue is proactively working
with law enforcement and government authorities nationwide to root out drug
diversion, including the illicit prescribing that can lead to diversion. It aims to distance Purdue from its past
conduct in deceptively marketing opioids, which gave rise to its 2007 criminal
plea, and make its current marketing seem more trustworthy and truthful. In fact, Purdue has consistently failed to
report suspicious prescribing it observed to authorities.

151.
Purdue
can track distribution and prescriptions of its opioids down to the retail and
prescriber level. It has detailed data
on opioid prescribing and sales and, through its extensive network of sales
representatives, can observe signs of diversion.

152.
Purdue
identified those doctors – internally. Since at least 2002, Purdue maintained a
database of health care providers suspected of inappropriately prescribing
OxyContin or other opioids. Physicians
could be added to this database based on observed indicators of illicit
prescribing such as excessive numbers of patients, cash transactions, patient
overdoses, and unusual prescribing of the highest-strength pills (80 mg OxyContin
pills or “80s,” as they were known on the street, were a prime target for diversion).
Health care providers added to the
database no longer were detailed, and sales representatives received no
compensation tied to these providers’ prescriptions.

153.
Yet,
Purdue failed to cut off these providers’ opioid supply at the pharmacy
level—meaning Purdue continued to generate sales revenue from their
prescriptions—and failed to report these providers to state medical boards or
law enforcement. In an interview with the
Los Angeles Times, which first
reported this story, Purdue’s former senior compliance officer acknowledged
that in five years of investigating suspicious pharmacies, the company never
stopped the supply of its opioids to a pharmacy, even where Purdue employees
personally witnessed the diversion of its drugs.

154.
The
same was true of prescribers. Despite Purdue’s
knowledge of illicit prescribing from one Los Angeles, CA clinic which its
district manager called an “organized drug ring,” Purdue did not report its
suspicions from 2009 until 2013—long after law enforcement shut it down and not
until the ring prescribed more than 1.1 million OxyContin tablets.

155.
The NY
AG found that Purdue placed 103 New York health care providers on its No-Call List
between January 1 2008 and March 7, 2015, and that Purdue’s sales
representatives had detailed approximately two-thirds of these providers, some
quite extensively, making more than a total of 1,800 sales calls to their
offices over a six-year period” and spending approximately $3,000 dollars in
meal expenses for 38 of these providers.[47] Upon information and belief, similar
practices occurred throughout New Jersey, including in Newark.

156.
The NY
AG has found that Endo knew, as early as 2011, that Opana was being abused in
New York, but certain sales representatives who detailed New York health care
providers testified that they did not know about any policy or duty to report
problematic conduct. The NY AG further
determined that Endo detailed health care providers who were subsequently
arrested or convicted for illegal prescribing of opioids a total of 326 times,
and these prescribers collectively wrote 1,370 scripts for Opana ER (although
the subsequent criminal charges at issue did not involve Opana ER). Upon information and belief, Endo engaged in
similar practices throughout New Jersey, including in Newark.

157.
Defendants’
misrepresentations prompted health care providers to prescribe, patients to
take, and payors to cover opioids for the treatment of chronic pain. Through its early marketing, Purdue overcame
barriers to widespread prescribing of opioids for chronic pain with deceptive
messages about the risks and benefits of long-term opioid use. Through their continued deceptive marketing,
including to the present, Defendants have both benefited from and extended
their prior misrepresentations, sustaining and expanding a market for their
opioids.

158.
Defendants’
deceptive marketing substantially contributed to an explosion in the use of
opioids. Approximately 20% of the
population between the ages of 30 and 44, and nearly 30% of the population over
45, have used opioids. Opioids are the
most common treatment for chronic pain, and 20% of office visits now include
the prescription of an opioid.

159.
Both
historically and currently, Purdue accounts for the lion’s share of sales of
brand name opioids. In 2013, there were
6 million prescriptions of OxyContin, resulting in $2.6 billion in sales—giving
Purdue 44% of market value for ER/LA opioids, and 24% of the overall market
(which includes widely prescribed generics).
No other branded drug accounts for more than 3% of the ER/LA
prescriptions annually.[48]

160.
Overall
sales of opioids in New Jersey have skyrocketed, and Newark is no exception.

161.

The increase in opioid
prescribing corresponds with Defendants’ marketing push. As shown in the chart below, according to
data obtained from a marketing research company, Purdue spent roughly $15
million per quarter in 2000. Its
spending decreased from 2000 to 2007, as the company came under investigation
by the U.S. Department of Justice and various state attorneys general. But by 2010, with the introduction of Butrans
and reformulated OxyContin, Purdue ramped up its marketing once again. In 2011, Purdue’s marketing spiked to more
than $25 million per quarter, and by the end of 2015, with the introduction of
Hysingla ER, it soared to more than $40 million per quarter.

162.
The
largest component of this spending was attributable to sales representative
visits to individual prescribers, with total detailing expenditures rising from
roughly $45 million annually in 2000 to more than $108 million in 2014.

163.
Purdue
devotes these resources to detailing—notwithstanding increasing efforts of
hospitals and physician practice groups to restrict access—because it knows the
effectiveness of in-person marketing.
The effects of sales calls on prescribing behavior are well-documented
in the literature, including in a 2009 study correlating the nearly 10-fold
increase in OxyContin prescriptions between 1997 and 2002 to Purdue’s doubling
of its sales force and trebling of sales calls.

164.
Not
only Purdue, but also Cephalon, Endo and Janssen, devoted and continue to
devote massive resources to direct sales contacts with doctors. In 2014 alone,
Defendants spent $166 million on detailing branded opioids to doctors. This
amount is twice as much as Defendants spent on detailing in 2000. The amount
includes $108 million spent by Purdue, $34 million by Janssen, $13 million by
Cephalon, and $10 million by Endo. Purdue, Janssen, and Cephalon made visits to
doctors in Newark at which they promoted their opioids. Upon information and belief, Endo also
detailed doctors in Newark and promoted its opioids during those visits.

166.
Through
third parties, Defendants also continue to obfuscate the manifest link between
detailing and access to opioids. For
example, the Purdue-funded Center for Lawful Access and Abuse Deterrence
maintains a fact sheet on its website labeling as “myth” the notion that
“[i]ncreased access to controlled substances is directly related to . . .
aggressive marketing tactics to prescribers by pharmaceutical sales
representatives.”

167.
The
vast market for opioids is sustained today not only by Defendants’ ongoing
marketing, but also by their past, deception-fueled success in establishing
opioids as a first-line treatment for chronic pain—through patients who believe
they will not become addicted, addicts who demand more drugs, and health care
providers who refill opioid prescriptions that maintain dependence and
addiction in the belief they are doing the best for their patients or have no
other option but to prescribe more opioids.
Defendants’ marketing of opioids as the answer to pain reinforces the
psychological incentives for doctors to make their patients feel better—if they
provide opioids, the patient is appeased; if they do not, they face a patient
who feels underserved and may, with Defendants’ encouragement, seek another
doctor who will.

168.
The
sharp increase in opioid use resulting from Defendants’ marketing has led
directly to a dramatic increase in opioid abuse, addiction, overdose, and death
throughout the United States, including in the City. Representing the NIH’s National Institute of
Drug Abuse in hearings before the Senate Caucus on International Narcotics
Control in May 2014, Dr. Nora Volkow explained that “aggressive marketing by
pharmaceutical companies” is “likely to have contributed to the severity of the
current prescription drug abuse problem.”[49]

169.
In
August 2016, then U.S. Surgeon General Vivek Murthy published an open letter to
physicians nationwide, enlisting their help in combating this “urgent health
crisis” and linking that crisis to deceptive marketing. He wrote that the push to aggressively treat
pain, and the “devastating” results that followed, had “coincided with heavy
marketing to doctors . . . . [m]any of [whom] were even taught—incorrectly—that
opioids are not addictive when prescribed for legitimate pain.”[50]

170.
Scientific
evidence demonstrates a close link between opioid prescriptions and opioid
abuse. For example, a 2007 study found
“a very strong correlation between therapeutic exposure to opioid analgesics,
as measured by prescriptions filled, and their abuse,”[51]
with particularly compelling data for extended release oxycodone—i.e., OxyContin.

171.
In a
2016 report, the CDC explained that “[o]pioid pain reliever prescribing has
quadrupled since 1999 and has increased in parallel with [opioid] overdoses.” Patients receiving opioid prescriptions for
chronic pain account for the majority of overdoses. For these reasons, the CDC concluded that
efforts to rein in the prescribing of opioids for chronic pain are critical “to
reverse the epidemic of opioid drug overdose deaths and prevent opioid-related
morbidity.”[52]

172.
Opioids
were involved in 42% of all fatal drug overdoses in 2015, and another 25%
involved heroin. According to the CDC,
between 1999 and 2015, more than 194,000 people died in the United States from
prescription-related overdoses. At least
1,901 people are reported to have died from opioid overdoses in New Jersey last
year. Deaths involving heroin have more
than doubled, and fentanyl-related deaths have risen 2,000%, since 2013.

173.
Purdue’s
conduct has significantly harmed veterans.
Sixty percent (60%) of veterans returning from deployment suffer from
chronic pain, double the national average of thirty percent (30%) of U.S.
citizens. Veterans are twice as likely
to suffer addiction and to die from opioid abuse than non-veterans according to
a 2011 Veterans Administration study.

174.
Overdose
deaths are only one consequence. Opioid
addiction and misuse also result in an increase in emergency room visits,
emergency responses, and emergency medical technicians’ administration of
naloxone—the antidote to opioid overdose. Naloxone has been used more than 18,000 times
in New Jersey since 2014.

175.
Rising
opioid use and abuse have negative social and economic consequences far beyond
overdoses. According to a recent analysis by a Princeton University economist,
approximately one out of every three working age men who are not in the labor
force take daily prescription pain medication.
The same research finds that opioid prescribing alone accounts for 20%
of the overall decline in the labor force participation for this group from
2014-16, and 25% of the smaller decline in labor force participation among
women. Many of those taking painkillers
still said they experienced pain daily.

176.
There
are also swelling costs from the growing universe of medications aimed at
treating secondary effects of opioids—including not only addiction and
overdose, but also side effects like constipation and sedation. According to a recent analysis by The Washington Post, working age women
and men on opioids are much more likely to have four or more prescriptions from
a physician (57% and 41%, respectively) than their counterparts who do not take
opioids (14% and 9%, respectively).
These secondary-effects medications—essentially, drugs to treat the
effects of opioids—generated at least $4.6 billion in spending nationally in
2015, on top of $9.57 billion in spending on opioids themselves. In addition, there are also the costs of
dispensing opioids—in office visits to obtain refills, count pills, or obtain
toxicology screens to monitor potential abuse.

177.
The
deceptive marketing and overprescribing of opioids also had a significant
detrimental impact on children. The
overprescribing of opioids for chronic pain has given young children access to
opioids, nearly all of which were prescribed for adults in their
household. 11.8% of New Jersey high
school students in 2013 reported having taken prescription drugs such as
OxyContin, Percocet, Vicodin, codeine, Adderall, Ritalin, or Xanax at least
once.

178.
Even
infants have not been immune to the impact of opioid abuse. There has been a dramatic rise in the number
of infants who are born addicted to opioids due to prenatal exposure and suffer
from neonatal abstinence syndrome (“NAS,” also known as neonatal opioid
withdrawal syndrome, or “NOWS”). These
infants painfully withdraw from the drug once they are born, cry nonstop from
the pain and stress of withdrawal, experience convulsions or tremors, have
difficulty sleeping and feeding, and suffer from diarrhea, vomiting, and low
weight gain, among other serious symptoms.
The long-term developmental effects are still unknown, though research
in other states has indicated that these children are likely to suffer from
continued, serious neurologic and cognitive impacts, including hyperactivity,
attention deficit disorder, lack of impulse control, and a higher risk of
future addiction. When untreated, NAS
can be life-threatening. In 2009, more
than 13,000 infants in the United States were born with NAS, or about one every
hour. In New Jersey, the incidence of
NAS more than doubled between 2006 and 2013, from roughly 2.5 infants per 1,000
hospital births to 5.2 per 1,000, which would amount to 532 infants in 2013.

179.
Children
are also injured by the dislocation caused by opioid abuse and addiction.

180.
Opioids
now outpace other sources of addiction in demand for substance abuse
treatment. In Essex County, where
roughly half of all admissions to substance abuse treatment centers occur in
Newark, heroin and other opiates represent 49% of all admission, almost equaling
the number of admissions for alcohol, cocaine, marijuana, and all other drugs
combined.

181.
Defendants’
success in extending the market for opioids to new patients and chronic
conditions also created an abundance of drugs available for non-medical or criminal
use and fueled a new wave of addiction, abuse, and injury.

182.
Contrary
to Defendants’ misrepresentations, most of the illicit use originates from prescribed opioids. It has been estimated that 60% of the opioids
that are abused come, directly or indirectly, through physicians’
prescriptions. In 2011, 71% of people
who abused prescription opioids got them through friends or relatives, not from
drug dealers or the internet. Often,
patients on prescription opioids fail pill checks or other strategies recommended
to monitor addiction, are discharged by their doctors, and then turn to heroin
as an alternative.

183.
Because
heroin is cheaper than prescription painkillers, many prescription opioid
addicts migrate to heroin. Roughly 80%
of heroin users previously used prescription opioids. A recent, even more deadly problem stemming
from the prescription opioid epidemic involves fentanyl—a powerful opioid
carefully prescribed for cancer pain or in hospital settings that, in synthetic
form, has made its way into New Jersey communities.

184.
The City
has incurred substantial expense to address the opioid epidemic created by
Defendants’ misconduct and to reimburse prescriptions paid for through its
self-insured workers’ compensation insurance.

I.
Although Defendants
knew that their Marketing Of Opioids was false and misleading, they
fraudulently concealed their misconduct

185.
Defendants
made, promoted, and profited from their misrepresentations about the risks and
benefits of opioids for chronic pain even though they knew that their marketing
was false and misleading. The history of
opioids, as well as research and clinical experience over the last 20 years,
established that opioids were highly addictive and responsible for a long list
of very serious adverse outcomes. The FDA and other regulators warned Defendants
of this, and likewise, Purdue and Cephalon paid hundreds of millions of dollars
to address similar misconduct that occurred before 2008. Defendants had access
to scientific studies, detailed prescription data, and reports of adverse
events, including reports of addiction, hospitalization, and deaths—all of
which made clear the harms from long-term opioid use and that patients are
suffering from addiction, overdoses, and death in alarming numbers. More
recently, the FDA and CDC have issued pronouncements based on existing medical
evidence that conclusively expose the known falsity of Defendants’
misrepresentations.

186.
Notwithstanding
this knowledge, at all times relevant to this Complaint, Defendants took steps
to avoid detection of and to fraudulently conceal their deceptive marketing and
unlawful, unfair, and fraudulent conduct. Defendants disguised their own role in the
deceptive marketing of chronic opioid therapy by funding and working through
biased science, unbranded marketing, third party advocates, and professional
associations. Purdue, Endo, Cephalon, and
Janssen purposefully hid behind the assumed credibility of these sources and
relied on them to establish the accuracy and integrity of Defendants’ false and
misleading messages about the risks and benefits of long-term opioid use for
chronic pain. Purdue, Endo, Cephalon, and
Janssen masked or never disclosed their role in shaping, editing, and approving
the content of this information. Defendants
also distorted the meaning or import of studies it cited and offered them as
evidence for propositions the studies did not support.

187.
Purdue
thus successfully concealed from the medical community, patients, and the City facts
sufficient to arouse suspicion of the claims that the City now asserts. The City did not know of the existence or
scope of Defendants’ fraud and could not have acquired such knowledge earlier
through the exercise of reasonable diligence.

190.
In
overstating the benefits of and evidence for the use of opioids for chronic
pain and understating their very serious risks, including the risk of
addiction; in falsely promoting abuse-deterrent formulations as reducing abuse;
in falsely claiming that OxyContin provides 12 hours of relief; and in falsely
portraying their efforts or commitment to rein in the diversion and abuse of
opioids, including in Newark, Defendants have engaged in misrepresentations and
knowing omissions of material fact.

191.
Specifically, misrepresentations and false
pretenses include, but are not limited to:

a.
Defendants’ claims that the risks of long-term opioid
use, especially the risk of addiction were overblown;

b.
Defendants’ claims that signs of addiction were
“pseudoaddiction” reflecting undertreated pain, and should be responded to with
more opioids;

i.
Purdue’s claims OxyContin provides a full 12 hours of
pain relief; and

j.
Purdue’s and Endo’s claims that they cooperate with and
support efforts to prevent opioid abuse and diversion.

192.
By engaging in the acts and practices alleged
herein, Defendants omitted to state material facts, with the intent that others
rely on their omissions or suppression of information, that they had a duty to
disclose by virtue of Defendants’ other representations, including, but not
limited to, the following:

a.
opioids are highly addictive and may result in overdose
or death;

b.
no credible scientific evidence supports the use of
screening tools as a strategy for reducing abuse or diversion;

c.
high dose opioids subject the user to greater risks of
addiction, other injury, or death;

d.
exaggerating the risks of competing products, such as
NSAIDs, while ignoring the risks of hyperalgesia, hormonal dysfunction, decline
in immune function, mental clouding, confusion, and dizziness, increased falls
and fractures in the elderly, neonatal abstinence syndrome, and potentially
fatal interactions with alcohol or benzodiazepines;

e.
Defendants’ claims regarding the benefits of chronic
opioid therapy lacked scientific support or were contrary to the scientific
evidence;

f.
Purdue’s 12-hour OxyContin fails to last a full twelve
hours in many patients;

g.
Purdue and Endo’s abuse-deterrent formulations are not
designed to address, and have no effect on, the most common route of abuse (oral
abuse), can be defeated with relative ease; and may increase overall abuse; and

h.
Purdue and Endo failed to report suspicious
prescribers.

193.
Defendants’ statements about the use of opioids
to treat chronic pain were not supported by or were contrary to the scientific
evidence, as confirmed by the CDC and FDA.

194.
Further, Defendants’ omissions, which were false
and misleading in their own right, rendered even seemingly truthful statements
about opioids false and misleading and likely to mislead
City prescribers and consumers when taken in the context of the surrounding
circumstances.

195.
Defendants’
acts and practices regarding prescribers and consumers as alleged in this
Complaint are unconscionable commercial practices and are immoral, unethical,
and offensive to established public policy, including:

· The policy, reflected in the City’s and
the State of New Jersey’s efforts in this regard, to promote mental health and prevent
substance abuse, and specifically, to curb the opioid epidemic in Newark;

· The policy,
reflected by the New Jersey Division of Consumer Affairs’ guidelines’ that
patients be informed about opioids’ side effects and drug interactions, receive
the lowest dose and smallest quantity of opioids, that the CDC Guideline
recommending non-opioid approaches such as physical therapy, be followed.

· The policy,
reflected in New Jersey Administrative Code Title
13, Chpt. 45H and the creation of a Suspicious Activity Report (“SAR”) portal
to facilitate reports,of reporting suspicious orders to authorities;

196.
Defendants’ acts and practices
as alleged constituted unfair competition.
At all times relevant to this Complaint, Purdue promoted OxyContin as
providing 12 hours of pain relief, and promoted abuse-deterrent formulations of
its opioids as more difficult to abuse and less addictive, as means of
maintaining a competitive advantage against other opioid pharmaceuticals. At
all times relevant to this Complaint, Defendants promoted opioids as superior
to competing products, such as NSAIDs, and exaggerated the risks of NSAIDs
while ignoring risks of adverse effects of opioids.

197.
The City
is part of the broad class of persons that may avail themselves of a remedy
under N.J. § 56:8-19.

198.
The City
has been injured as a direct and proximate result of
Defendants’ violations of the Consumer Fraud Act as alleged in this Complaint.

199.
The City has suffered
ascertainable loss of money or property as a result of Defendants acts and
practices alleged in this Complaint.

200.
Defendants
are liable for three times the City’s actual damages and reasonable attorneys’
fees, filing fees, and reasonable costs of suit.

COUNT II
Public Nuisance
(Against All Defendants)

201.
Plaintiff incorporates the allegations within
all prior paragraphs within this Complaint as if they were fully set forth
herein.

202.
A public nuisance is an unreasonable
interference with a right common to the general public, such as a condition
dangerous to health, offensive to community moral standards, or unlawfully
obstructing the public in the free use of public property.

203.
Defendants’ conduct significantly
interfered, and continues to significantly interfere, with the public health
and safety, the public peace, and the public comfort. Defendants’ had control over their conduct in
Newark and that conduct had an adverse effect on the public right. The public nuisance has significantly
harmed any considerable number of the State’s residents.

204.
Defendantsknew and
should have known that their promotion of opioids was false and misleading and
that their deceptive marketing scheme and other unlawful, unfair, and
fraudulent actions would create or assist in the creation of a public nuisance.

205.
Defendants have created or assisted in the
creation of a condition that is injurious to public health, public safety,
public peace, public comfort and public convenience, and offends the moral
standards of communities throughout the State and significantly harmed any
considerable number of the State’s residents.

206.
The public nuisance is substantial and
unreasonable. Defendants’ actions caused and continue to cause the public
health epidemic and state of emergency described in the complaint, and that
harm outweighs any offsetting benefit.

207.
Defendants, individually and acting through
their employees and agents, and in concert with each other, have intentionally,
recklessly, or negligently engaged in conduct or omissions which endanger or
injure the property, health, safety or comfort of a considerable number of
persons in Newark by their production, promotion, and marketing of opioids for
use by residents of Newark.

208.
Defendants’ actions were, at the very least, a
substantial factor in opioids becoming widely available and widely used, in deceiving
healthcare professionals and patients about the risks and benefits of opioids
for the treatment of chronic pain, and in the public health crisis that
followed.

209.
Defendants’ conduct in creating and maintaining
the public nuisance were neither fully regulated nor required by any federal or
New Jersey law, and in fact were contrary to public policy and guidance from
the FDA and CDC.

210.
The public nuisance—i.e., the opioid epidemic—created,
perpetuated, and maintained by Defendants can be abated and further recurrence
of such harm and inconvenience can be abated.

211.
The City has been, and continues to be, directly
and proximately injured by Defendants’ actions in creating a public nuisance.

212.
Plaintiff suffered special injuries
distinguishable from those suffered by the general public.

213.
Defendants’ conduct was accompanied by wanton
and willful disregard of persons who foreseeably might be harmed by their acts
and omissions.

214.
Plaintiff incorporates the allegations within
all prior paragraphs within this Complaint as if they were fully set forth
herein.

215.
Defendants, individually and acting through
their employees and agents, made misrepresentations and omissions of facts
material to Plaintiff and its residents to induce them to purchase, administer,
and consume opioids as set forth in detail above.

216.
In
overstating the benefits of and evidence for the use of opioids for chronic
pain and understating their very serious risks, including the risk of
addiction; in falsely promoting abuse-deterrent formulations as reducing abuse;
in falsely claiming that OxyContin provides 12 hours of relief; and in falsely
portraying their efforts or commitment to rein in the diversion and abuse of
opioids, including in Newark, Defendants have engaged in misrepresentations and
knowing omissions of material fact.

217.
Specifically, misrepresentations or omissions
include, but are not limited to:

a.
Defendants’ claims that the risks of long-term opioid
use, especially the risk of addiction were overblown;

b.
Defendants’ claims that signs of addiction were
“pseudoaddiction” reflecting undertreated pain, and should be responded to with
more opioids;

i.
Purdue’s claims OxyContin provides a full 12 hours of
pain relief; and

j.
Purdue’s and Endo’s claims that they cooperate with and
support efforts to prevent opioid abuse and diversion.

218.
By engaging in the acts and practices alleged
herein, Defendants omitted to state material facts that it had a duty to
disclose by virtue of Defendants’ other representations, including, but not
limited to, the following:

a.
opioids are highly addictive and may result in overdose
or death;

b.
no credible scientific evidence supports the use of
screening tools as a strategy for reducing abuse or diversion;

c.
high dose opioids subject the user to greater risks of
addiction, other injury, or death;

d.
exaggerating the risks of competing products, such as
NSAIDs, while ignoring the risks of hyperalgesia, hormonal dysfunction, decline
in immune function, mental clouding, confusion, and dizziness, increased falls
and fractures in the elderly, neonatal abstinence syndrome, and potentially
fatal interactions with alcohol or benzodiazepines;

e.
Defendants’ claims regarding the benefits of chronic
opioid therapy lacked scientific support or were contrary to the scientific
evidence;

f.
Purdue’s 12-hour OxyContin fails to last a full twelve
hours in many patients;

g.
Purdue and Endo’s abuse-deterrent formulations are not
designed to address, and have no effect on, the most common route of abuse
(oral abuse), can be defeated with relative ease; and may increase overall
abuse; and

h.
Purdue and Endo failed to report suspicious
prescribers.

219.
Defendants’ statements about the use of opioids
to treat chronic pain were not supported by or were contrary to the scientific
evidence, as confirmed by the CDC and FDA.

220.
Further,
Defendants’ omissions, which were false and misleading in their own right,
rendered even seemingly truthful statements about opioids false and misleading
and likely to mislead City prescribers and consumers when taken in the context
of the surrounding circumstances.

221.
Defendants knew at the time that they made their
misrepresentations and omissions that they were false.

222.
Defendants intended that the City and its
residents would rely on their misrepresentations and omissions.

223.
The City and its healthcare providers and residents
reasonably relied upon Defendants’ misrepresentations and omissions.

224.
By reason of their reliance on Defendants’
misrepresentations and omissions of material fact the City suffered actual
pecuniary damage.

225.
Defendants’ conduct was accompanied by wanton
and willful disregard of persons who foreseeably might be harmed by their acts
and omissions.

COUNT
IV
Unjust Enrichment
(Against All Defendants)

226.
The City incorporates the allegations within all
prior paragraphs within this Complaint as if they were fully set forth herein.

227.
As an expected and intended result of their
conscious wrongdoing as set forth in this Complaint, Defendants have profited
and benefited from opioid purchases made by the City.

228.
In exchange for the opioid purchases, and at the
time the City made these payments, the City expected that Defendants had not
engaged in deceptive practices or practices contrary to the City’s public
policy and had not misrepresented any material facts regarding those risks.

229.
Defendants have been unjustly enriched at the
expense of the City.

PRAYER
FOR RELIEF

231.
A finding that by the acts alleged herein,
Defendants have created a public nuisance;

232.
An award of three
times the City’s actual damages under N.J. Stat. Ann. § 56:8-19;

233.
For an injunction permanently enjoining Purdue
from engaging the acts and practices that caused the public nuisance;

234.
For an order directing Purdue to abate and pay
damages for the public nuisance;

235.
For compensatory and punitive damages for
Purdue’s fraud and negligent misrepresentation;

236.
For restitution or disgorgement of Purdue’s unjust
enrichment, benefits, and ill-gotten gains, plus interest, acquired as a result
of the unlawful or wrongful conduct alleged herein pursuant to common law;

[12]
Allegations made upon information and belief in subsequent paragraphs of this
Complaint are likewise based on Defendants’ use of nationwide sales practices
and evidence that statements or omissions were made, or practices used,
elsewhere.

[14]Partners
Against Pain consists of both a website, styled as an “advocacy community”
for better pain care, and medical education resources distributed to
prescribers by the sales force. It has
existed since at least the early 2000s and has been a vehicle for Purdue to
downplay the risks of addiction from long-term opioid use. One early pamphlet, for example, answered
concerns about OxyContin’s addictiveness by claiming: “Drug addiction means using a drug to get
‘high’ rather than to relieve pain. You
are taking opioid pain medication for medical purposes. The medical purposes are clear and the effects
are beneficial, not harmful.”

[25] The
FDA has warned other drug makers that claims of improved function and quality
of life were misleading. See, Warning Letter from Thomas Abrams,
Dir., FDA Div. of Mktg., Adver., & Commc’ns, to Doug Boothe, CEO, Actavis
Elizabeth LLC (Feb. 18, 2010), available
at (rejecting claims that Actavisthe opioid, Kadian, had an “overall
positive impact on a patient’s work, physical and mental functioning, daily
activities, or enjoyment of life.”); Warning Letter from Thomas Abrams, Dir.,
FDA Div. of Mktg., Adver., & Commc’ns, to Brian A. Markison, Chairman,
President and Chief Executive Officer, King Pharmaceuticals, Inc. (March 24,
2008), (finding the claim that “patients who are treated with [Avinza (morphine
sulfate ER)] experience an improvement in their overall function, social
function, and ability to perform daily activities . . . has not been
demonstrated by substantial evidence or substantial clinical
experience.”). The FDA’s warning letters
were available to Defendants on the FDA website.

[34] CDC Guideline at 19. The 2016 CDC Guideline
reinforces earlier findings announced by the FDA. In 2013, the FDA acknowledged
“that the available data do suggest a relationship between increasing opioid
dose and risk of certain adverse events.” For example, the FDA noted that studies
“appear to credibly suggest a positive association between high-dose opioid use
and the risk of overdose and/or overdose mortality.”

[47]
Attorney General of the State of New York, In the Matter of Purdue Pharma L.P.,
Assurance No.: 15-151, Assurance of Discontinuance Under Executive Law Section
63, Subdivision 15 at 5.

[48]
During the same period, Purdue accounted for 47% of branded prescription
revenue, 39% of long-acting opioid revenue, and 55% of branded-long acting
revenue. In the last 4 years, from
2013-2016 coinciding with the removal of generic versions of long-acting
oxycodone and the introduction of generic versions of common short-acting
drugs, Purdue’s market share of branded drugs has increased to 81%.